Manufacturing Quality Engineer

Manufacturing Quality Engineer – Medical Devices

Help ensure quality in products that improve lives

Join a team dedicated to developing and manufacturing innovative medical devices that make a meaningful impact on patient care. As a Manufacturing Quality Engineer, you'll play a critical role in ensuring products meet quality, safety, and regulatory requirements throughout the product lifecycle.

In this role, you'll partner closely with manufacturing, engineering, operations, and supplier teams to drive product quality, solve complex problems, support regulatory compliance, and continuously improve manufacturing processes. This is an excellent opportunity for a quality professional who enjoys hands-on collaboration, data-driven decision-making, and making a direct impact on product performance and patient safety.

• Serve as the quality representative on manufacturing and product development projects.
• Partner with engineering and operations teams to ensure compliance with quality system requirements and regulatory standards.
• Lead and support investigations related to nonconforming materials (NCMRs), CAPAs, and manufacturing quality issues.
• Perform root cause analysis and implement effective corrective and preventive actions.
• Collaborate with suppliers to resolve quality concerns and drive supplier corrective actions.
• Support First Article Inspections (FAIs), change order reviews, receiving inspection activities, and other day-to-day quality operations.
• Participate in product risk management activities, including PFMEA, DFMEA, risk assessments, and risk management documentation.
• Review and approve quality documentation, protocols, reports, and manufacturing records.
• Support design verification, validation, process validation, and manufacturing process improvements.
• Provide guidance on sampling plans, statistical analysis, and data-driven quality decisions.
• Participate in design reviews and cross-functional discussions to ensure quality and risk considerations are addressed early in development.
• Support complaint investigations and ensure timely, compliant documentation.
• Train and support team members on quality processes, procedures, and inspection requirements.
• Drive continuous improvement initiatives that improve product quality, manufacturing efficiency, and compliance.

• Bachelor's degree in Engineering, Science, Technology, or a related field, or equivalent combination of education and experience.
• 3+ years of Quality Engineering, Quality Assurance, or Manufacturing Quality experience within a regulated industry.
• Experience working within a Quality Management System (QMS).
• Experience with CAPA, NCMR, root cause investigations, and corrective action processes.
• Knowledge of risk management tools such as PFMEA, DFMEA, and risk assessments.
• Experience supporting manufacturing operations and production quality activities.
• Understanding of process validation, verification, and quality control methodologies.
• Strong analytical, problem-solving, and decision-making skills.
• Ability to review technical documentation, engineering drawings, and specifications.
• Strong communication skills and the ability to work effectively across cross-functional teams.

• Medical device industry experience.
• Experience with catheter-based products, disposable medical devices, or other complex medical technologies.
• Knowledge of FDA Quality System Regulations and ISO 13485 requirements.
• Experience working in a contract manufacturing, CDMO, or high-volume manufacturing environment.
• Experience with supplier quality management and supplier corrective actions.
• Knowledge of statistical methods, sampling plans, and data analysis techniques.
• Experience supporting verification, validation, sterilization, or manufacturing process qualification activities.
• Familiarity with GD&T and interpretation of engineering drawings.
• Continuous improvement experience using Lean, Six Sigma, or related methodologies.

• Work on products that directly impact patient health and outcomes.
• Partner with highly skilled engineering, manufacturing, and quality professionals.
• Gain exposure to the full medical device product…